Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 21 for:    MSC | Bronchopulmonary Dysplasia

Human Mesenchymal Stem Cells For Infants At High Risk For Bronchopulmonary Dysplasia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03774537
Recruitment Status : Unknown
Verified March 2019 by Xia Yunqiu, Children's Hospital of Chongqing Medical University.
Recruitment status was:  Recruiting
First Posted : December 13, 2018
Last Update Posted : March 6, 2019
Sponsor:
Information provided by (Responsible Party):
Xia Yunqiu, Children's Hospital of Chongqing Medical University

Tracking Information
First Submitted Date  ICMJE December 12, 2018
First Posted Date  ICMJE December 13, 2018
Last Update Posted Date March 6, 2019
Actual Study Start Date  ICMJE March 1, 2019
Estimated Primary Completion Date December 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 12, 2018)
Number of participants with adverse reactions related to infusion after treatment [ Time Frame: 24 hours after administration ]
To evaluate the safety of hUC-MSCs for BPD.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 12, 2018)
  • The incidence and severity of BPD defined by the National Institutes of Child Health and Human Development (NICHD) workshop. [ Time Frame: at the corrected gestational age of 36 weeks ]
    To evaluate the efficacy of hUC-MSCs to prevent preterm infants at high risk of BPD from developing BPD
  • Changes of high-resolution chest CT in participants [ Time Frame: within 2 years after administration ]
    To evaluate the safety and efficacy of human umbilical cord -derived mesenchymal stem cells for BPDmesenchymal stem cells for BPD.
  • Changes of temperature in participants [ Time Frame: 3 days after administration ]
    To evaluate the safety of human umbilical cord -derived mesenchymal stem cells for BPD.mesenchymal stem cells for BPD.
  • Changes of blood pressure in participants [ Time Frame: 3 days after administration ]
    To evaluate the safety of human umbilical cord -derived mesenchymal stem cells for BPD. Blood pressure is measured by electronic sphygmomanometer.
  • Changes of respiratory rate in participants [ Time Frame: 3 days after administration ]
    To evaluate the safety of human umbilical cord -derived mesenchymal stem cells for BPD.
  • Changes of oxygen saturation in participants [ Time Frame: 3 days after administration ]
    To evaluate the safety of human umbilical cord -derived mesenchymal stem cells for BPD.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Human Mesenchymal Stem Cells For Infants At High Risk For Bronchopulmonary Dysplasia
Official Title  ICMJE Intravenous Human Umbilical-Cord-Derived Mesenchymal Stem Cells For Premature Infants At High Risk For Bronchopulmonary
Brief Summary This study is an open-label, single-center, dose escalation study to evaluate of safety and efficacy of human umbilical cord -derived mesenchymal stem cells (hUC-MSCs) in premature infants at high risk for Bronchopulmonary Dysplasia(BPD)
Detailed Description

BPD is a chronic lung disease that occur in premature infants receiving prolonged oxygen pulmonary and ventilator therapy. It remains a main complication of extreme prematurity and currently lacks efficient treatment.The mortality rate of one year after birth is still high and the quality of life is not optimistic.

hUC-MSCs are widely used in clinic due to their low immunogenicity and convenient to get. Many animal study had shown that hUC-MSCs had therapeutic effects on a variety of animal models of lung disease.Furthermore,there are a large number of clinical trials of MSCs applied to various system diseases and the safety was verified.So, the main purpose of this study is to evaluate the safety and efficacy of hUC-MSCs in participants at high risk for BPD

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Bronchopulmonary Dysplasia
Intervention  ICMJE
  • Drug: Transplantation of hUC-MSCs
    Preterm infants at high risk for BPD will receive transplantation of hUC-MSCs through intravenous infusion. Dose A - 1 million cells per kg; Dose B - 5 million cells per kg
    Other Name: Intravenous infusion of hUC-MSCs
  • Drug: No transplantation of hUC-MSCs
    Preterm infants at high risk for BPD will not receive transplantation of hUC-MSCs
    Other Name: No intravenous infusion of hUC-MSCs
Study Arms  ICMJE
  • Experimental: Transplantation of hUC-MSCs
    Preterm infants at high risk for BPD will receive transplantation of hUC-MSCs.
    Intervention: Drug: Transplantation of hUC-MSCs
  • No transplantation of hUC-MSCs
    Preterm infants at high risk for BPD will not receive transplantation of hUC-MSCs
    Intervention: Drug: No transplantation of hUC-MSCs
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 12, 2018)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2021
Estimated Primary Completion Date December 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. An infant whose postnatal age is 3 to 14 days, inclusive (for treatment between 5 and 14 days after birth)
  2. Gestational age is between 23 and 28 weeks (23 weeks ≤ gestational age (GA) < 28 weeks)
  3. Birth weight is between 500g and 1000g, inclusive
  4. Being intubated and receiving mechanical ventilation within 5-14 days after birth, with a fraction of inspired oxygen (FiO2) of 0.25 or greater at Screening
  5. Written consent form signed by a legal representative or a parent.

Exclusion Criteria:

  1. Although mechanical ventilation or oxygen is required in participants, there are no signs of dyspnea or BPD-related changes in lung imaging, such as central apnea or diaphragm paralysis.
  2. The participants who have complex congenital heart disease.
  3. The participants who have severe pulmonary hypertension(cardiac ultrasound confirmed) at the time of assessment.
  4. The participants who have severe respiratory tract malformation: pierre-robin syndrome, tracheobronchomalacia, vascular ring syndrome, congenital tracheal stenosis, tracheo-esophageal fistula, pulmonary emphysema, pulmonary sequestration, congenital pulmonary dysplasia, congenital pulmonary cyst, congenital spasm, etc.
  5. The participants who have severe chromosome anomalies :Edward syndrome, Patau syndrome, Down syndrome, etc) or severe congenital malformation (Hydrocephalus, Encephalocele, etc).
  6. The participants who have severe congenital infection(Herpes, Toxoplasmosis, Rubella, Syphilis, AIDS, etc).
  7. The participants who have severe sepsis or shock.
  8. The participants who is going to have surgery 72 hours before/after this study drug administration.
  9. The participants who have surfactant administration within 24 hours before this study drug administration.
  10. The participants who have severe intracranial hemorrhage ≥ grade 3 or 4.
  11. The participants who have active pulmonary hemorrhage or active air leak syndrome at the time of assessment.
  12. The participants who have the history of other clinical studies as a participant.
  13. The participants who is considered inappropriate by the investigators.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 14 Days   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03774537
Other Study ID Numbers  ICMJE XiaYQ
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Xia Yunqiu, Children's Hospital of Chongqing Medical University
Study Sponsor  ICMJE Children's Hospital of Chongqing Medical University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Zhou Fu Children's Hospital of Chongqing Medical University
PRS Account Children's Hospital of Chongqing Medical University
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP